Oral Green Tea Extract for Small Cell Lung Cancer

Small Cell Lung Carcinoma Clinical Trial

Official title:

Phase ⅠStudy of Oral Green Tea Extract as Maintenance Therapy for Extensive-stage Small Cell Lung Cancer

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT01317953
• Other study ID #: GTESCLC2011
• Status: Available

Study information

• Verified date: April 2019
• Source: Shandong Cancer Hospital and Institute
• Contact: Xindong Sun, M.D.
• Phone: 0086-053167626141
• Email: zhx7152028[@]yahoo.com.cn
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

The purpose of this study is to determine whether green tea extract is safe for extensive-stage small lung cancer who achieved objective tumor response after first-line therapy.

Description:

Small-cell lung cancer accounts for 13 to 15% of all lung cancer and more than 60 to 70% of patients present with extensive disease (ED). Although etoposide plus cisplatin (EP) regimen has been the mainstay of ED-SCLC treatment, median overall survival is about 9 months, with 5 to 10% surviving two years and only 1% of patients achieving a long-term disease-free survival. To improve this outcome further, various attempts have been made, which included dose intensification with stem cell supports, maintenance therapy, and also searches for a better chemotherapy regimen.

Significant anticarcinogenic effects of green tea extract on various organs, such as skin, stomach, duodenum, colon, liver, pancreas, and lung in rodent models have been confirmed. Recent scientific investigations have identified the active chemical compounds in green tea designated tea polyphenols or catechins. Epigallocatechin-3-gallate (EGCG) is the major catechin in tea.An investigation about the effects of EGCG on human SCLC cells revealed that EGCG had similar anti-tumor effects on drug-sensitive (H69) and drug-resistant (H69VP) SCLC cells. Thus, the investigators conduct this phase I trial, the objectives of this trial were to study the side effects and best dose of of EGCG in treating patients with small-cell lung cancer who achieved objective tumor response after first-line therapy.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of small cell lung cancer

• extensive-stage disease

• Eastern Cooperative Oncology Group performance status (PS) of 0 to 2

• age18 years old

• Adequate bone marrow reserves: neutrophil (ANC) count = 1500 /mm^3, platelet count = 100,000 /mm^3, hemoglobin = 9 g/dl

• Adequate renal function: serum creatinine = 1.5 mg/dl and/or calculated creatinine clearance = 60 ml/min

• Adequate hepatic function: bilirubin level = 1.5 x ULN, ASAT & ALST = 1.5 x ULN

• Signed written informed consent prior to study entry

• According to Response Evaluation Criteria in Solid Tumors(RECIST), patients didn't progress after first-line chemotherapy

Exclusion Criteria:

• Any condition that would hamper informed consent or ability to comply with the study protocol

• Participation in another research study in the last three months

• Known malignancy at any site other than SCLC

• Recent consumption of green tea (5 or more cups per day within one week of study enrollment)

• Pregnant and lactating women

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to EGCG

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Dietary Supplement:
• epigallocatechin gallate
Starting dose green tea catechin extract "EGCG" 400 mg twice a day (BID) of EGCG (400 mg caps BID), second escalated dose 800 mg BID of EGCG (2x400 mg caps BID), third escalated dose 1200 mg BID of EGCG (3x400 mg),fourth escalated dose 1600 mg BID of EGCG (4x400 mg),and fifth escalated dose 2000 mg BID of EGCG (5x400 mg),

Locations

Country	Name	City	State
China	Shan Dong cancer hospital and institute	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China,